Once-Monthly Maridebart Cafraglutide for the Treatment of Obesity — A Phase 2 Trial
Authors' conclusion
In this phase 2 trial, once-monthly maridebart cafraglutide resulted in substantial weight reduction in participants with obesity with or without type 2 diabetes.
Study context
- Population
- Adults with obesity (obesity cohort: 465; female 63%, mean age 47.9 years, mean BMI 37.9) and with obesity and T2D (obesity-diabetes cohort: 127; female 42%, mean age 55.1 years, mean BMI 36.5)
- Participants
- 592 adults2 cohorts
- Comparison
- Once-monthly maridebart cafraglutide (MariTide) at various doses/schedules vs placebo
- Primary endpoint
- Percent change in body weight from baseline
- Follow-up
- Week 52
Methodological detailsphase 2, double-blind, placebo-controlled, dose-ranging, 11 groups as two cohorts
- Phase 2
- Double-blind
- Placebo-controlled
- Dose-ranging
- 11 groups as two cohorts
Primary result
As reported in the abstract
Mean percent change in body weight (treatment policy estimand) · baseline to week 52
Obesity cohort: maridebart cafraglutide, range across doses
−12.3% (95% CI, −15.0 to −9.7) to −16.2% (95% CI, −18.9 to −13.5)
Obesity cohort: placebo
−2.5%
95% CI −4.2 to −0.7
Obesity-diabetes cohort: maridebart cafraglutide, range across doses
−8.4% (95% CI, −11.0 to −5.7) to −12.3% (95% CI, −15.3 to −9.2)
Obesity-diabetes cohort: placebo
−1.7%
95% CI −2.9 to −0.6
Further findings
- Mean change in HbA1c, obesity-diabetes cohort · treatment policy estimand — Placebo
- mean 0.1 percentage points
- Mean change in HbA1c, obesity-diabetes cohort — Maridebart cafraglutide (range across groups)
- −1.2 to −1.6 percentage points
Safety
- GI adverse events were common with maridebart cafraglutide, although less frequent with dose escalation and a lower starting dose
- No unexpected safety signals emerged
Original publication
Once-Monthly Maridebart Cafraglutide for the Treatment of Obesity — A Phase 2 Trial. N Engl J Med. Published 23 June 2025. doi:10. 1056/ nejmoa2504214
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